Uni-Bio Science Group Limited) has obtained successful Phase III clinical trial results of Uni-PTH, a once-daily prescription new drug for osteoporosis.
Uni-PTH achieved its primary efficacy endpoint of statistically significant superiority over current treatment after 12 months in post-menopausal women. The randomized, open label, multicenter study enrolled 502 patients to receive either Uni-PTH or positive control (Calcitonin) with Calcichew D. Uni-PTH showed a significant difference versus positive control at increasing lumbar spine bone mass density after 12 months of treatment (6.92% vs 2.78%, p<0.01). Other biochemical markers measured during the trial confirmed the novel mechanism of Uni-PTH as an anabolic (bone growing) agent. In addition, Uni-PTH continues to exhibit a good safety profile, consistent with past trials and that of similar drugs.
Mr. Tong Kit Shing, Chairman and Executive Director of Uni-Bio Science Group said, "We couldn't be any happier with the reported results of Uni-PTH. This drug is the first of our drugs we have developed from the initial stage all the way to almost commercialization. This is definitely the biggest milestone for the Group's R&D team up to date."
The global osteoporosis market may reach up to USD$11.4 billion by 2015. China is one of the fastest expanding markets, growing at approximately 13.5% according to the latest forecast, and it has the potential to reach USD$2.5 billion by 2015. "As the only class of available treatment that stimulates new bone formation and actively rebuild weakened bones, Uni-PTH may change the treatment paradigm of osteoporosis in China by providing an alternative and more effective treatment to patients, especially those with severe osteoporosis. We believe Uni-PTH can improve the quality-of-life for many patients; this is a major value proposition of the drug. In view of the lucrative market it is in, we believe Uni-PTH will have strong prospects once it is launched" Mr. Tong concluded.
Source: ACN Newswire
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